Norva Studio
A qualified workspace for statistical programming, where the environment that produced a result is recorded as a property of the work rather than reconstructed for an audit afterwards.
Why it matters here
Indian CROs and sponsor teams often run several studies for several clients on shared infrastructure, with different R versions and package sets accumulating study by study. When a result is questioned two years later, the environment is usually the part nobody can reproduce.
Studio makes the workspace the evidence. The R build, the package versions and the qualification record travel with the study rather than living in a colleague's notes.
- Validated R environmentA managed build with a qualified package repository
- Version lockingThe study keeps the versions it ran on
- Environment snapshotsRestore the exact state a result came from
- Study workspacesSeparated per study and per client
- Git integrationCode, specifications and history in one place
- Browser basedRStudio and VS Code with no local install to control
Compliance and compute
The qualification evidence inspectors ask for is produced by the platform rather than assembled by hand: installation, operation and performance records for the environment, and validation records for the packages an analysis depends on.
Compute scales to the work rather than the other way round, which matters when a pooled analysis has to finish before a submission window closes.
- 21 CFR Part 11Audit trail and electronic signatures
- IQ, OQ and PQDocumentation generated for the environment
- Package validationEvidence for the analytical tooling itself
- Interactive and batchBoth on the same qualified environment
- Distributed computeFor pooled analyses and simulation
- Job schedulingRuns that repeat without being re-run by hand
Want your R environment qualified once rather than per study?
We will look at how it is managed today and what qualification currently costs you in time.